Midazolam
- Product NDC
- 70518-4328
- 11-digit product format
- 705184328
- Labeler code
- 70518
- Product ID
- 70518-4328_402f646b-1f17-d819-e063-6394a90ab1d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090315
- Marketing category
- ANDA
- Marketing start
- 2025-04-14
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 2 mg/2mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 2 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 1666798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4328-0 | Midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 70518-4328-1 | Midazolam | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4328 | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250418_d9305142-417d-4d8c-9a23-f9a1b6771cac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4328-0 | 70518432800 | 10 VIAL in 1 CARTON (70518-4328-0) / 2 mL in 1 VIAL (70518-4328-1) | 10 vial | 2025-04-14 | No | No | Current |
| 70518-4328-1 | 70518432801 | 2 mL in 1 VIAL | 2 ml | | | | Historical |